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    Summary
    EudraCT Number:2009-011850-17
    Sponsor's Protocol Code Number:H6D-EW-LVIK
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-09-04
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2009-011850-17
    A.3Full title of the trial
    A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Effect on Unassisted Erectile Function of the Early Use of Tadalafil 5 mg Once a Day and Tadalafil 20 mg On Demand Treatment for 9 Months in Subjects Undergoing Bilateral Nerve-Sparing Radical Prostatectomy
    A.3.2Name or abbreviated title of the trial where available
    LVIK
    A.4.1Sponsor's protocol code numberH6D-EW-LVIK
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEli Lilly and Company Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Cialis
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland BV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTADALAFIL
    D.3.9.1CAS number 171596-29-5
    D.3.9.2Current sponsor code450190
    D.3.9.3Other descriptive nameTadalafil
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Cialis
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland BV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTADALAFIL
    D.3.9.1CAS number 171596-29-5
    D.3.9.2Current sponsor code450190
    D.3.9.3Other descriptive nametadalafil
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Erectile dysfunction following Bilateral Nerve-Sparing Radical Prostatectomy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10050756
    E.1.2Term Radical prostatectomy
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10061461
    E.1.2Term Erectile dysfunction
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of tadalafil 5 mg once a day (OAD) and tadalafil 20 mg on demand (PRN), compared with placebo, when taken orally over 9 months, in improving unassisted erectile function in men who develop erectile dysfunction after bilateral nerve-sparing radical prostatectomy.
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of tadalafil 5 mg OaD on drug-assisted erectile function when administered to all subjects at the end of the 3-month, open-label period.
    - To evaluate the efficacy of tadalafil compared with placebo on drug-assisted erectile function at the end of the 9-month, placebo-controlled period.
    - To evaluate the efficacy of tadalafil compared with placebo on unassisted erectile function at the end of the washout period.
    - To evaluate the effect of tadalafil compared with placebo on penile length and girth.
    - To evaluate the effect of tadalafil compared with placebo on spontaneous morning erections.
    - To evaluate subjects’ satisfaction with tadalafil compared with placebo.
    - To evaluate subjects’ and partners’ quality of life following tadalafil compared with placebo.
    - To evaluate psychosocial outcomes of tadalafil compared with placebo.
    - To assess the safety of tadalafil 5 mg OaD and tadalafil 20 mg PRN, compared with placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Male and aged >=18 years at screening and <65 years at time of BNSRP.
    -Able to read, understand and provide signed informed consent.
    -Have no history of ED at screening and a normal preoperative erectile function score, without the use of therapy or devices for the improvement of erections.
    -Are scheduled to undergo bilateral NSRP surgery for organ-confined, non-metastatic prostate cancer up to approximately 6 weeks after screening.
    -Have an interest in resuming sexual activity as soon as possible after surgery and anticipate having the same adult female sexual partner during the study.
    -Have a historical total PSA level <10 ng/mL prior to screening.
    -Have a clinical stage of prostate cancer of T1c to T2c.
    -Have a biopsy Gleason score <=7.
    -Agree not to use any other treatment for ED, including herbal and over-the-counter (OTC) medications, during the study.
    -Agree to participate in recording responses to questionnaires and other instruments used in this study.
    Post-Surgical Inclusion Criteria
    -Have an operating report with confirmation of bilateral nerve-sparing during the prostatectomy procedure, as determined by a total (composite) score of 3 or less.
    -Have Grade 0-3 Residual Erectile Function, as measured at randomisation.
    -Have developed ED after surgery, as measured at randomisation.
    -Have a final pathological stage that does not require the initiation of adjuvant therapy for prostate cancer.
    E.4Principal exclusion criteria
    At screening :
    -Have a history of ED, with or without treatment.
    -Have a history of prostatic surgery or prostatic physical treatments.
    -Have a history of penile implant.
    -Have a history of drug, alcohol or substance abuse within the previous 6 month.
    -Have a history of galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption.
    At screening or randomisation:
    -Have received previous or current treatment with tadalafil or any other PDE5 inhibitor.
    -Require treatment with doxazosin or nitrates after randomisation or have received treatment with cancer chemotherapy, luteinising hormone-releasing hormone (LH-RH) analogues, LH-RH antagonists, or anti-androgens.
    -Have undergone, or plan to undergo, radiation or hormonal therapy for prostate cancer.
    -Have ED post-BNSRP caused by untreated endocrine disease.
    -Have a clinically significant penile deformity.
    -Have a communicable skin or sexually transmitted disease, or have any rash or lesions on the penis or surrounding area.
    -Exhibit evidence of clinically significant renal insufficiency.
    -Exhibit clinical evidence of severe hepatic impairment.
    -Have a history of diabetes mellitus.
    -Present with chronic stable angina treated with long-acting nitrates, or with chronic stable angina requiring short-acting nitrates in the previous 90 days, or with angina occurring during sexual intercourse in the previous 6 months.
    -Have met the criteria for unstable angina within the previous 6 months, or have a history of myocardial infarction or coronary artery bypass graft surgery within the previous 90 days, or percutaneous coronary intervention within the previous 90 days.
    -Have any supraventricular arrhythmia with an uncontrolled ventricular response (mean heart rate >100 bpm) at rest, or have any history of spontaneous or induced sustained ventricular tachycardia (heart rate >100 bpm for >=30 seconds), or use an automatic internal cardioverter-defibrillator.
    -Have a history of sudden cardiac arrest.
    -Exhibit any evidence of congestive heart failure (New York Heart Association [NYHA] Class II or above) within the previous 6 months.
    -Have a history of new significant cardiac conduction defect within the previous 90 days.
    -Exhibit systolic BP >170 or <90 mmHg or diastolic BP >100 or <50 mmHg (if stress is suspected, retest under basal conditions), or have a history of malignant hypertension.
    -Have a history of significant central nervous system injuries within the previous 6 months.
    -Have a history of loss of vision in one eye because of nonarteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.
    -Have a history of human immunodeficiency virus (HIV) infection.
    -Have any condition that, in the opinion of the investigator, would interfere with the subject’s ability to provide informed consent or comply with study instructions, would place the subject at increased risk, or might confound the interpretation of the study results.
    -Are investigator site personnel directly affiliated with this study and/or their immediate family. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
    -Are Lilly employees.
    -Are currently enrolled in, or have discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
    -Have previously completed or withdrawn from this study or any other study investigating tadalafil.
    Exclusion Criteria Post-Surgery
    -Require radiotherapy, hormonal or adjuvant anti-cancer therapy for prostate cancer, according to the investigator’s clinical judgment and as assessed by clinical and PSA findings.
    -Require further surgery due to haemorrhage, or have any evidence of local recurrence or occurrence of any metastasis.
    -Urethral catheter expected to be in place for >3 weeks due to anastomotic insufficiency or fistula.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of subjects with a score of >=22 in the IIEF-EF Domain after 6 week drug-free washout following the 9 months treatment period.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    The 9 month randomised treatment period is followed by a 3-month open label treatment period.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA53
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months24
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state41
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 392
    F.4.2.2In the whole clinical trial 412
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-09-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-11-02
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